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Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants

NCT00135486 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2016-09-16

No results posted yet for this study

Summary

The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant vaccines were given to all children to complete the vaccination agenda.

Conditions

  • Infections, Meningococcal

Interventions

BIOLOGICAL

MenC-TT

BIOLOGICAL

Hib-MenC-TT

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Weeks
Max Age
16 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2003-01-31
Completion
2003-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00135486 on ClinicalTrials.gov